-Caveat Lector- http://news.bbc.co.uk/hi/english/health/newsid_1027000/1027852.stm BBC News Online: Health Monday, 20 November, 2000, 00:03 GMT GPs 'give children unproven doses' GPs are prescribing a significant number of drugs to children in doses that have not been officially approved for use, according to research. Researchers found that the practice of prescribing drugs to children that are outside the terms of the product licence or not specified on the label (off-label) is widespread among GPs. There is evidence to suggest that adverse drug reactions among children in hospital are higher for off label and unlicensed drugs. Children deserve the same rights and benefits as adults Dr John McIntyre, University of Nottingham The research team examined the prescribing records for 1997 for one suburban general practice in the Midlands. Children up to the age of 12 represented one-fifth of this practice's list. Around two-thirds of them were given at least one prescription during the year. The practice records showed there were almost 3,500 prescriptions for almost 1,200 children involving 160 different drugs. Some 84% of the drugs had been prescribed for licensed medicines within the terms of the product licence. Less than half of one per cent were for unlicensed medicines, but one in 10 were for off label licensed medicines. Almost all of these involved using dosages that were not recommended on the label. By far the most frequently prescribed off label drugs were antibiotics. Other off-label drugs included anti-asthmatic medications, creams, and antihistamines. GPs not to blame The authors stress that GPs are not to blame for the current situation. Instead, say the authors, they are victims of inadequate product licence information which recommends, for example, that the same dose of a commonly prescribed antibiotic should be given to a new-born and a 10-year-old. Licensing, say the authors, is unable to keep abreast of current practice and there is no system to monitor and co-ordinate the information. There is also little incentive for the pharmaceutical industry to carry out research on drugs that are already licensed, and funding for research into the way medicines are used in children is not considered a high priority. However, they go on to say: "It is essential that the regulatory framework ensures medicines in children are safe, effective, and of high quality." Lead researcher Dr John McIntyre, from the University of Nottingham, said research had found that adverse reactions to drugs among children occurred in 6% of unlicensed or off-label medicines, compared with 3.9% of licensed prescriptions. He stressed that these figures could not be directly extrapolated to drugs prescribed by GPs. However, he told BBC News Online: "The current position is unacceptable. "The licensing framework is there to ensure patients receive safe, effective, high quality drugs - children deserve the same rights and benefits as adults." Drug company response Richard Ley, a spokesman for the Association of the British Pharmaceutical Industry, said that more could be done to improve testing of drugs on children, and said his organisation was negotiating to get international agreement on a more satisfactory system. However, he told BBC News Online: "The situation is not as bad as the headline would suggest. "Clinicians who deal with children are not blind guessing about drugs, they have a huge body of knowledge and shared experience of these medications and they know what they are doing." Mr Ley said it was difficult to carry out trials of drugs on children because few volunteers could be found. "If you ask a parent if they want their child to take a medication that has not previously been tested on children, they say no. "Anyone who is a parent understands that reaction, but clearly it makes it difficult to find volunteers to take part in trials." The research is published in the journal Archives of Disease in Childhood. © BBC =========================== http://news.bbc.co.uk/hi/english/health/newsid_1028000/1028364.stm BBC News Online: Health Monday, 20 November, 2000, 00:15 GMT Parents 'not told of drug errors' Almost half the parents whose children received the wrong medication after hospital mistakes were never informed of the error, research has found. The survey, covering five years of work at a paediatric teaching hospital in Scotland, revealed fewer mistakes than expected. But the level of secrecy surrounding the blunders did surprise the researchers. The medical profession in the UK has come rather late to admitting openly that adverse medical incidents including medication errors are an important problem Royal Hospital for Sick Children The study was carried out at the Royal Hospital for Sick Children in Glasgow - one of the UK's leading specialist centres for children and babies requiring complex and risky treatment. It found that one mistake occurred for every 662 patients admitted to the hospital, although most of these happened in children under the age of two. Three-fifths of the mistakes happened on medical wards, and six out of ten were made by nurses, rather than doctors, as nurses are often responsible for measuring out the right quantity of drugs for patients. Most errors minor Most of the errors were classed as "minor", even though 10% required some extra treatment to rectify. The study authors said they believed doctors and nurses in some cases recorded the incident as minor in order to deflect criticism and possible repercussions. It's not in the spirit of openness if doctors are acting as Gods Mike Stone, Patient's Association However, in 48% of cases, the parents were never told what had happened to their children. The report's authors commented: "The medical profession in the UK has come rather late to admitting openly that adverse medical incidents, including medication errors, are an important problem." In 15 cases, the error involved giving either 10 times too much, or 10 ten times too little of the drug concerned - an error which can prove fatal in some circumstances. Many of the mistakes involved anti-cancer drugs, intravenous feeding or fluids. Encouragingly, however, the research found that when extra checks and training were put in place by the hospital, the error rate dropped significantly. Mike Stone, of the Patients' Association, told BBC News Online: "It's not in the spirit of openness if doctors are acting as Gods and withholding information that patients need. "There should be complete openness, that's very important after Alder Hey, Bristol and North Staffordshire. "Fortunately there are younger doctors who have had some communication training, but when something like this happens, it shows that there is still an awfully long way to go." The research was published in the journal Archives of Disease in Childhood. Related to this story: Hospital gave children drug overdose (17 Dec 99 | Health) Hospital blunder poisoned baby girl (08 Dec 99 | Health) © BBC ============================= http://news.bbc.co.uk/low/english/health/newsid_754000/754237.stm BBC News Online: Health Thursday, 18 May, 2000, 16:27 GMT 17:27 UK Drug firms attacked over child medicines The Consumers' Association says too many drugs are being used on child patients without full testing or licensing. Children are being denied the same rights as adults in the provision of properly-tested drugs Consumers' Association About 40% of the drugs used in paediatric medicine have either no explicit licence for use on child patients, or are used "off-label" by doctors. This means they are licenced for children, but are being prescribed for conditions not covered by the licence. In the treatment of newborn babies, as many as 65% of commonly-used drugs fall into these categories. Drug manufacturers usually conduct adult trials on new medicines. This is because is it ethically simpler to obtain consent from adults than from children or their parents - and there are usually far more adult patients with a particular condition, making it easier to draw together the large groups needed for a well-constructed trial. Parents are normally unwilling to allow their children to participate in a clinical trial. Dr Trevor Jones, the director general of the Association of the British Pharmaceutical Industry (ABPI), said: "There are practical and ethical issues involved in testing medicines particularly where infants or babies may be involved. It is simply unethical to carry out experimental studies on babies unless we are convinced it is safe to do so." 'Rights denied' Clara Mackay, from the Consumers' Association, said: "Children are being denied the same rights as adults in the provision of properly-tested drugs. "Parental consent for testing new treatments or procedures with children is understandably an issue of concern. But we are equally concerned that children are being prescribed medicines every day which have not been tested or licensed for such use." The association sent out letters to 80 pharmaceutical companies asking them to outline their policies on trials involving children, but only a handful replied. The ABPI complained that the letters had only been sent out at the end of April, and that two weeks was not long enough to formulate a "reasoned response to a serious issue." The Royal College of Paediatrics and Child Health recently published the first ever guide to the safe use of adult drugs in children, giving guidance on safe dosages and side-effects. The ABPI said that it hoped to have an international system for licensing medicines for five different age groups agreed in November. The Consumers' Association campaign has been backed by the medical charity Action Research. Action Research paediatrician Dr Mike Shields, of the Queen's University of Belfast, said: "The way that the body gets rid of drugs is very different in children compared with adults. "We need data that tells us which drugs are safe to use with children and what dose to give them." A spokesman for the Royal College of Nursing also called for the licensing of medicines prescribed for children to be tightened. Paediatric nursing adviser Sue Barr said: "Parents are bound to be worried by this report - children can't be treated as `small adults' when drugs are being prescribed." © BBC **COPYRIGHT NOTICE** In accordance with Title 17 U. S. C. Section 107, any copyrighted work in this message is distributed under fair use without profit or payment to those who have expressed a prior interest in receiving the included information for nonprofit research and educational purposes only. 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